Brief Summary

Surgical intervention to treat a inguinal hernia is a very common pediatric surgical procedure, often performed using an inguinal incision. Children who undergo hernia repair can suffer from a significant degree of discomfort postoperatively. The investigators are evaluating the effectiveness of an ultrasound guided caudal-epidural (CE) block to an US guided ilioinguinal/iliohypogastric (IIG/IHG) nerve block in achieving post operative analgesia following a hernia repair. It is hypothesized that US guided IIG/IHG nerve block leads to more effective pain control post-operatively while in hospital relative to an US guided CE block for inguinal hernia surgery.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach

1 country

2 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 years study duration

Study Start

First participant enrolled

September 1, 2015

Completed

1.4 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2017

Completed

2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed

Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

3 years

First QC Date

February 1, 2017

Last Update Submit

November 9, 2017

Conditions

Hernia, Inguinal Pain, Postoperative

Keywords

Inguinal herniaCaudal nerve blockIlioinguinal nerve blockPain

Outcome Measures

Primary Outcomes (5)

Post-operative pain
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale is out of 10 and is used in children who have difficulty verbalizing pain and in sleeping children (regardless of age).
Immediately following the procedure
Post-operative pain
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale is out of 10 and is used in children who have difficulty verbalizing pain and in sleeping children (regardless of age).
15 minutes post-operatively
Post-operative pain
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale is out of 10 and is used in children who have difficulty verbalizing pain and in sleeping children (regardless of age).
30 minutes post-operatively
Post-operative pain
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale is out of 10 and is used in children who have difficulty verbalizing pain and in sleeping children (regardless of age).
60 minutes post-operatively
Post-operative pain
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale is out of 10 and is used in children who have difficulty verbalizing pain and in sleeping children (regardless of age).
120 minutes post-operatively

Secondary Outcomes (3)

Post-operative pain
24 hours post-operatively
Total ibuprofen consumption
Up to 24 hours post-operatively
Total acetaminophen consumption
Up to 24 hours post-operatively

Study Arms (2)

Caudal-epidural nerve block

ACTIVE COMPARATOR

All patients will receive acetaminophen (15mg/kg) within one hour of induction of anesthesia. Inhalation induction of anesthesia will be performed with sevoflurane in 100% O2. A single dose of up to 2-4 mg/kg of propofol and Remifentanil 0.5-1mcg/kg will be given prior insertion of a laryngeal mask airway or endotracheal tube. Anesthesia will be maintained with Propofol and Remifentanil (2.5mcg/ml) which will be started at 300 mcg/kg/min and titrated to effect. If necessary additional boluses of Propofol (1mg/kg) and/or Remifentanil (0.5-1mcg/kg) and/or Morphine 0.05mg/kg boluses IV will be administered. Ondansetron (0.1mg/kg) and Dexamethasone (0.15mg/kg) will be given as antiemetic prophylaxis for all patients. Ketorolac 0.3mg/kg will be given to each patient. The CE group will receive an US-confirmed CE nerve block with 0.8 mL/kg of 0.2% ropivacaine (maximum 15 mL).

Procedure: Caudal-epidural nerve blockDrug: AcetaminophenDrug: SevofluraneDrug: RemifentanilDrug: PropofolDrug: MorphineDrug: OndansetronDrug: DexamethasoneDrug: Ketorolac

ilioinguinal/iliohypogastric nerve block

EXPERIMENTAL

All patients will receive acetaminophen (15mg/kg) within one hour of induction of anesthesia. Inhalation induction of anesthesia will be performed with sevoflurane in 100% O2. A single dose of up to 2-4 mg/kg of propofol and Remifentanil 0.5-1mcg/kg will be given prior insertion of a laryngeal mask airway or endotracheal tube. Anesthesia will be maintained with Propofol and Remifentanil (2.5mcg/ml) which will be started at 300 mcg/kg/min and titrated to effect. If necessary additional boluses of Propofol (1mg/kg) and/or Remifentanil (0.5-1mcg/kg) and/or Morphine 0.05mg/kg boluses IV will be administered. Ondansetron (0.1mg/kg) and Dexamethasone (0.15mg/kg) will be given as antiemetic prophylaxis for all patients. Ketorolac 0.3mg/kg will be given to each patient. The IIG/IHG group will receive a unilateral US guided IIG/IHG with 0.4mL/kg of ropivacaine 0.2% (max 12 mL).

Procedure: Ilioinguinal/iliohypogastric nerve blockDrug: AcetaminophenDrug: SevofluraneDrug: RemifentanilDrug: PropofolDrug: MorphineDrug: OndansetronDrug: DexamethasoneDrug: Ketorolac

Interventions

Ilioinguinal/iliohypogastric nerve blockPROCEDURE

See arm description

ilioinguinal/iliohypogastric nerve block

Caudal-epidural nerve blockPROCEDURE

See arm description

Caudal-epidural nerve block

AcetaminophenDRUG

See arm description